Medical Device Developments的动态

?? Clario secures FDA approval for SpiroSphere system with wireless ECG The system is designed to run with the COR-12, a compact and wireless ECG device that transmits 12-channel ECG data via Bluetooth. SpiroSphere enables consecutive collection of spirometry and ECG data during a single site visit, using the company’s SpiroSphere platform. It consolidates all data into a single, unified database, simplifying the clinical trial process and eliminating the need for separate ECG devices or multiple databases for a study. Read more online: https://lnkd.in/e6Y4hgK5 ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

?? Imperative Care gets FDA approval for Zoom 6F Insert Catheters According to Imperative Care, Zoom 6F represents the first insert catheter portfolio specifically developed for ischemic stroke procedures, based on physician feedback. The portfolio includes the Zoom SIM, Zoom VRT, and Zoom VTK technologies, with unique shapes, construction, and length, to help physicians achieve faster intracranial access. Imperative Care said that its catheters are designed to be more supportive, more torque-able and longer than current vessel selection devices. Read more online: https://lnkd.in/eJ22TBhM ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

?? Johnson & Johnson MedTech gets FDA approval for Varipulse platform to treat AFib The Varipulse Platform is a pulsed field ablation (PFA) system that comprises the Varipulse Catheter, Trupulse Generator, and CARTO 3 Mapping System. CARTO 3 is a 3D electro-anatomical cardiac mapping system that enhances mapping capabilities to simplify procedures, reduce procedure time, and improve outcomes. The FDA approval of the Varipulse platform is based on data from the admIRE study, a multi-centre, non-randomised clinical trial in 291 patients across 30 healthcare centres in the US. Read more online: https://lnkd.in/eqxNhsEV ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

?? The second MDCG Guidance of the year was released ? The Medical Device Coordination Group (MDCG) just published the second guidance of the year. MDCG 2024-02, on the procedures for the updates of the European Medical Device Nomenclature (EMDN).??? ? This guidance explains how the nomenclature will be annually reviewed and updated based on the EMDN use and related users’ feedback. ? ?? Have a look at our latest article on the topic -> https://lnkd.in/eFPEsUs4 #medicaldevices #guidance #news

The Medical Device Coordination Group (MDCG) has released a new version of MDCG 2022-9, “Summary of Safety and Performance Template”. Changes since the first release in 2022 include clarification on when the Summary of Safety and Performance (SSP) should be made available to patients, alignments with MDCG 2019-9 rev.2, and the replacement of “Intended use of the device” with “Intended purpose and other indications”, along with other minor updates." Want to see what has changed in detail? https://lnkd.in/dAgYnkE5 Source of the document: https://lnkd.in/dDu3HT-b All MDCG documents can be found here: https://lnkd.in/eQJ7zvz9 #medicaldevices #astracon #mdcg #ivdr

???? Medtronic gets FDA nod for expanded MRI labelling for DBS systems The US FDA has approved expanded MRI labelling for Medtronic Percept PC and Percept RC, as well as Medtronic Activa PC, RC and SC. The MRI labelling approval, which applies exclusively to Medtronic DBS systems, permits extended active scan time for scans within specified B1+rms limits. The approval enhances diagnostic and functional assessment options. Medtronic is claimed to be the first in the US to provide full-body MR Conditional DBS systems that enable patients to undergo scans anywhere on the body under specific conditions safely. Read more online: https://lnkd.in/eKQdZrfG ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

Navigating the regulatory landscape for cardiac medical devices can be challenging. Whether your device follows the 510(k) pathway (for lower-risk devices), PMA (for high-risk devices like implantable defibrillators), or IDE (for investigational devices), each has its own requirements. Choosing the right regulatory path is crucial to ensure patient safety and timely market entry. ?? Need help understanding which pathway is right for your device? Learn more in our latest blog post: https://bit.ly/3UJqCYp #MedicalDevices #Cardiology #RegulatoryCompliance #FDA #HealthTech #Quroba

?? Johnson & Johnson MedTech’s Impella ECP shows safety and efficacy in IDE study The IDE study is the first clinical trial completed on patients supported with Impella ECP, a novel transvalvular axial flow pump with compressible pump architecture. Impella ECP technology is developed by Abiomed, a company of Johnson & Johnson MedTech. The IDE study established the safety and efficacy of Impella ECP in high-risk percutaneous coronary intervention (PCI), with a major adverse cardiac and cerebrovascular events (MACCE) rate of 6.3%. Read more online: https://lnkd.in/e9_MiTst ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter #MedicalDeviceDevelopments #medicaldevices #medicalmanufacturing

We are thrilled to announce that the ReActiv8 Restorative Neurostimulation system has received regulatory approvals for full-body MR conditional labeling in the European Union, the United Kingdom and Australia. This means that all current and future ReActiv8 patients in Europe and Australia implanted with the commercially available 45 cm leads have the ability to undergo 1.5T full-body scans. ? The MRI approvals were achieved in connection with Mainstay receiving certificates issued by its Notified Body confirming conformity with the Medical Device Regulations (MDR) of both the European Union and the United Kingdom.?Specific scan conditions and safety information are provided in the ReActiv8 MRI Guidelines manuals for each territory. Read the full press release here → https://lnkd.in/e3sFBmPJ. #mainstaymedical?#reactiv8 #multifidusdysfunction?#chroniclowbackpain #restorativetherapy?#thinkrestorative?#restorativerevolution #lowbackpain #clbp?#helpingpatients?#patientfocus #puttingpatientsfirst

MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature Fonte https://lnkd.in/eQJ7zvz9 al capitolo "European Medical Device Nomenclature (EMDN)" #MDCG #EMDN #medicaldevice #dispositivimedici #MedicalConsulting